Kornimate/medical-research-clean huggingface dataset:
study of the efficacy and safety of cholecalciferol supplementation on the activity of rheumatoid arthritis in patients with vitamin d deficiency

Conditions: Rheumatoid Arthritis; Vitamin D Deficiency

Summary: vitamin d plays a key role in the regulation of calcium metabolism and bone physiology and also presents immunomodulatory effects. in contrast to healthy individuals, macrophages and synoviocytes synovium of patients with rheumatoid arthritis (ra) have receptors for vitamin d. in vitro, 1,25 vitamin d inhibits t cell proliferation and cytokine synthesis and decreases pro-inflammatory process. there is an inverse relationship, at least in some epidemiological studies, between the circulating levels of 25oh vitamin d and the occurrence and / or activity of ra. the hypothesis of our study is that natural vitamin d supplementation in patients with ra and a vitamin d deficiency (vitamin d \<30 ng / ml) improves functional disability.

this is an interventional, multicenter (13 rheumatology units) randomized, double-blinded study against placebo, lasting 24 weeks. the main objective is to demonstrate that treatment with cholecalciferol improves functional disability (haq) in patients with ra not in remission (das28 vs\> 2.6 and the investigator does not think to change the treatment in the 3 months after enrolment) and vitamin d deficiency (vitamin d \<30 ng / ml). secondary objectives will be to examine whether there is a decrease in disease activity (tender joint count, swollen joint count, vas, eva activity, esr, crp, eular criteria, acr), a decrease in fatigue (facit eva - fatigue), improved quality of life (sf36, emir, pass, mos) and the impact of ra (raid).

Eligibility criteria:
inclusion criteria: - patients with ra (acr 1987) not in remission (das28\> 2.6) in whom no change in treatment is considered by the investigator for at least 3 months, dmard stable ra for at least 3 months and lack of infiltration in the last 2 months - serum 25-oh vitamin d \<30 ng / ml exclusion criteria: * arthritis resulting in class iv functional disability (according to the acr criteria) * hypercalcemia (serum calcium\> 2.6 mmol/l) and/or known hypercalciuria (calcium excretion\> 4 mg / kg / day), history of renal colic, thiazideic therapy. * known hypersensitivity to vitamin d * patient refused to sign the consent form, pregnant or nursing women, patients minor, major patients under protection of the act

Keywords: vitamin d rheumatoid arthritis cholecalciferol
a retrospective study to evaluate the conformis itotal® posterior stabilized (ps) knee replacement system

Conditions: Osteo Arthritis Knee

Summary: this study is a retrospective, multi-center study, with one single remote follow up contact. this study will include a minimum of 80 patients and a maximum 100 patients who have been treated with the conformis itotal ps knee product.

patients will be contacted either by phone or email for a single remote follow-up. retrospective data will be collected from medical records including pre-operative, operative and any follow up visits which have occurred since implantation as available. . all data will be collected from existing medical records and from single follow up call/email. * demographics and medical history * pre \& post-operative data including range of motion * surgical data * survivorship (phone/email or last known visit) * patient reported outcomes (phone/email single time point visit) * patient satisfaction * koos jr.

Eligibility criteria:
inclusion criteria: 1. previously underwent surgical implantation of a conformis itotal ps knee replacement. 2. over 18 years of age exclusion criteria: 1. bmi \> 40

Keywords: osteoarthritis knee arthroplasty knee replacement patient specific
human epilepsy genetics--neuronal migration disorders study

Conditions: Brain Malformation; Neuronal Migration Disorder; Cognition Disorder; Epilepsy

Summary: the purpose of this study is to identify genes responsible for epilepsy, brain malformations and disorders of human cognition.

epilepsy is responsible for tremendous long-term healthcare costs. analysis of inherited epilepsy conditions has allowed for identification of several key genes active in the developing brain. although many genetic abnormalities of the brain are rare and lethal, rapidly advancing knowledge of the structure of the human genome makes it a realistic goal to identify genes responsible for other epileptic conditions, related brain malformations and disorders of cognition. the purpose of this study is to identify genes responsible for epilepsy and disorders of human cognition (edhc). the walsh laboratory at boston children's hospital is looking for genes involved in brain development. conditions that we study include brain malformations, such as polymicrogyria, lissencephaly, pachygyria, heterotopias, microcephaly and cerebellar hypoplasia, and inherited disorders of cognition, such as familial intellectual disability and familial autism. people with these conditions also often have epilepsy. the structural brain abnormalities are usually diagnosed by brain mri or sometimes ct scans. adults and children with these conditions, and their family members, are invited to participate in our study. by comparing the dna of individuals or families that carry edhc to the dna of people in the general population, it may be possible to learn more about the genetic bases of certain forms of edhc. study participants must have a brain malformation or disorder of cognition, such as familial intellectual disability or autism, in order to take part in this research.

Eligibility criteria:
inclusion: * males and females of any age. * persons with a brain malformation or disorder of cognition (familial intellectual disability \[previously known as mental retardation\] or autism). exclusion: * persons without a brain malformation or disorder of cognition (familial intellectual disability (previously known as mental retardation\] or autism).

Keywords: epilepsy seizures disorders of human cognition neuronal migration neuronal migration disorders lissencephaly schizencephaly polymicrogyria heterotopia microcephaly pachygyria
a clinical study of cht101 in cd70-positive advanced solid tumors

Conditions: Relapsed / Refractory Solid Tumor

Summary: evaluate the safety and efficacy of cd70-targeting ucar-t cells in the treatment of cd70-positive advanced solid tumors.

4 planned dose cohorts will be evaluated during dose escalation phase. the dose expansion will be initiated after src (safety review committee) review the avaliable safety, pk and preliminary efficacy data.

Eligibility criteria:
inclusion criteria: 1. ability to understand and sign a written informed consent documen； 2. at the date of signing icf, 18 \~70 years old, male or female； 3. histopathological confirmed advanced or metastatic solid tumors patients who have failed to standard treatment or intolerance with standard treatment； 4. positive cd70 expression; 5. at least one measurable lesion at baseline per recist version 1.1； 6. the expected survival time is more than 12 weeks; 7. ecog 0-1 points; 8. adequate organ functions;

Keywords: allogeneic car-t safety efficacy pk
crossover study to assess the efficacy of pt003 with and without a valved holding chamber in subjects with moderate to severe copd

Conditions: COPD

Summary: this is a randomized, phase iii, two-period, open-label, chronic-dosing (7 days), multi-center, crossover study to assess the efficacy of pt003 in subjects with moderate to severe copd with and without a valved holding chamber.


Eligibility criteria:
inclusion criteria: * at least 40 years of age and no older than 80 at screening * women of non-child bearing potential or negative serum pregnancy test at screening, and agrees to acceptable contraceptive methods used consistently and correctly screening until 14 days after final visit. * subjects with an established clinical history of copd as defined by the american thoracic society (ats)/european respiratory society (ers) * current or former smokers with a history of at least 10 pack-years of cigarette smoking * pre- and post-bronchodilator fev1/fvc ratio of \<0.70 * post-bronchodilator fev1 must be \<80% predicted normal value, calculated using nhanes iii reference equations, and the measured fev1 must also be ≥30% of predicted normal value. exclusion criteria: * significant diseases other than copd, i.e., disease or condition which, in the opinion of the investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study. * women who are pregnant or lactating or women of childbearing potential who are not using an acceptable method of contraception. * subjects, who in the opinion of the investigator, have a current diagnosis of asthma. * subjects who have been hospitalized due to poorly controlled copd within 3 months prior to screening or during the screening period. * subjects who have poorly controlled copd, defined as acute worsening of copd that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to screening or during the screening period. * subjects who have clinically significant uncontrolled hypertension. * subjects who have cancer that has not been in complete remission for at least five years. * subjects with abnormal liver function tests defined as ast, alt, or total bilirubin ≥1.5 times upper limit of normal at screening and on repeat testing. * subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of whether or not they have been treated. subjects with a diagnosis of open angle glaucoma who have intraocular pressure controlled with medication(s) are eligible. * subjects with symptomatic prostatic hypertrophy that is clinically significant in the opinion of the investigator. subjects with a trans-urethral resection of prostate (turp) or full resection of the prostate within 6 months prior to screening are excluded from the study. * subjects with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the investigator.
mea112997 open-label long term extension safety study of mepolizumab in asthmatic subjects

Conditions: Asthma

Summary: this is a multi-centre, open-label long term safety study of 100 milligrams (mg) mepolizumab administered subcutaneously (sc) in addition to standard of care in subjects who participated in the mea112997 study. at each clinic visit, adverse events will be assessed and exacerbations will also be reviewed.


Eligibility criteria:
inclusion criteria: * informed consent. * mea112997 study participation: received at least 2 doses of double-blind investigational product during the mea112997 trial. * mea112997 treatment assignment: if the subject received mepolizumab, they must have had a positive risk: benefit ratio. * currently being treated with a controller medication and the subject has been on a controller medication for the past 12 weeks. * male or eligible female subjects. to be eligible for entry into the study, females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control for the duration of the trial and for 4 months after the last study drug administration. exclusion criteria: * hypersensitivity related to mepolizumab. * clinically significant change in health status since completing participation in the mea112997 trial. * a current malignancy or previous history of cancer in remission for less than 12 months prior to screening. * for those subjects who had a sae in mea112997 that was assessed as possibly related to mepolizumab by the investigator. * subjects who are pregnant or breastfeeding. subjects should not be enrolled if they plan to become pregnant during the time of study participation. * screening ecg which has a clinically significant abnormality. * received xolair (omalizumab) within the past 130 days. * participated in a clinical trial within the past 30 days or have received investigational medication within five terminal half-lives of screen visit, whichever is longer. * current smokers.

Keywords: extension study severe refractory asthma safety sb-240563 mepolizumab eosinophils
a placebo-controlled trial with rfxiii administered to subjects with mild to moderate active ulcerative colitis

Conditions: Inflammation; Ulcerative Colitis

Summary: this trial is conducted in europe. the aim of the trial is to investigate the effect of recombinant factor xiii (rfxiii) administered to subjects with mild to moderate active ulcerative colitis (uc).


Eligibility criteria:
inclusion criteria: * diagnosis of ulcerative colitis for at least 3 months from the time of initial diagnosis. the diagnosis must have been confirmed by historical endoscopy and histology. the severity of disease must have been confirmed by endoscopy at screening * currently receiving oral aminosalicylates at approved doses of at least 2g/day for at least 6 weeks. doses of oral aminosalicylates should be stable for at least two weeks prior to dosing (visit 2) exclusion criteria: * diagnosis of uc limited to the rectum (ulcerative proctitis only, defined as less than 15 cm from the anal verge) * requiring hospitalisation for current episode of severe uc * use of biologic therapies for the treatment of uc within 12 weeks prior to dosing (visit 2) * treatment failures to anti-tumour necrosis factor-alfa (anti-tnf-a) agents (e.g. infliximab, adalimumab) * use of immunosuppressant agents (e.g. azathioprine) within 4 weeks prior to dosing (visit 2) * use of corticosteroids (oral, intravenous (i.v.), intramuscular (i.m.), or rectal ) within 14 days prior to dosing (visit 2) * use of enemas (corticosteroid or aminosalicylate) within 14 days prior to screening (visit 1) * use of cyclosporine, tacrolimus, d-penicillamine, leflunomide, methotrexate, mycophenolate mofetil, or thalidomide within 4 weeks prior to dosing (visit 2) * currently receiving total parenteral nutrition
evaluation of dental maturation and mandibular bone morphology in childhood rheumatic diseases

Conditions: Childhood Rheumatic Diseases

Summary: the aim of our study is to examine possible disease-related changes in dental age and mandibular bone morphology in childhood rheumatic diseases.

to reveal the changes that can occur in different childhood rheumatic diseases, the treatment process of the disease and the drugs used on the dental age and mandible

Eligibility criteria:
inclusion criteria: * patients aged 6 to 14 years with childhood rheumatism * patients without bilateral congenital germ deficiency in the lower teeth * patients with seven teeth (except no #8) on the left of the mandibula (no seven teeth on the left of the mandibula, there should be a symmetrical tooth on the right of the mandibula. exclusion criteria: * patients with bilateral congenital germ deficiency in lower teeth in intraoral and/or radiographic examinations * patients with asymmetry and magnification errors and where anatomical structures cannot be seen clearly in the panoramic x-ray * patients with a significant number of missing teeth due to trauma or disease, root canal treatment, and pathological tooth structure * patients with a history of other chronic diseases

Keywords: childhood rheumatic diseases
therapeutic effect of low-dose prednisone combined with mmf and fk506 in focal segmental glomerulosclerosis

Conditions: Focal Segmental Glomerulosclerosis

Summary: the aim of this clinical trial is to determine the effect and security of low-dose prednisone combined with mmf and fk506 in focal segmental glomerulosclerosis.

focal segmental glomerular sclerosis (fsgs) is characterized by heavy proteinuria and nephritic syndrome in clinic. the major pathological change is scarring of the glomerulus that is focal and segmental. the incidence of fsgs is increasing in recent years, but no unified protocol for fsgs treatment has been provided. corticosteroid is the primary drug for fsgs treatment in clinic. however, corticosteroid treatment has a low response rate as 20% in clinic but some severe side-effects. the side-effects of long-term corticosteroid treatment urged researchers to find more reliable and secure methods for fsgs treatment. the new immunosuppressants shed light on fsgs treatment recently. the usage of immunosuppressants to fsgs treatment is in the preliminary stage and accounts for a few problems. the main problems include the uncertainty of curative effects, the lack of large-scale clinical trial, the side-effects of long-term application, and the high recurrence rate after withdraw. fsgs is immune-induced damage, which includes abnormality of many steps in humoral immunity and cellular immunity. according to it, we designed to inhibit the immune response at multi-targets with prednisone combined with mmf and fk506. thus the dosage of these drugs can be decreased to a secure level for long-term treatment while the side-effects can be controlled well. prednisone combined with mmf and fk506 then can be used to fsgs treatment with effectiveness and security.

Eligibility criteria:
inclusion criteria: * urinary protein≥1.0g/24h * biopsy-proved fsgs * age≥16years * understanding of the content of this study，signing informed consent form * adherence to drug taking and being able to be long-term followed up exclusion criteria: * sharp deterioration of renal function * refractory hypertension * secondary fsgs * serious disease of liver，active stage of viral hepatitis，or ast、alt≥2.5 times of baseline * serious myelosuppression * being unable to be long-term followed up

Keywords: focal segmental glomerulosclerosis prednisone mycophenolate mofetil fk506
emla topical cream for treatment of pain in patients receiving intra-dermal technetium 99 injections for lymphoscintigraphy for skin cancers

Conditions: Cutaneous Melanoma; Merkel Cell Carcinoma; Skin Squamous Cell Carcinoma

Summary: this phase ii trial tests how well emla topical cream works in treating pain in patients with skin cancers receiving technetium 99 injections for a lymphoscintigraphy mapping procedure. a lymphoscintigraphy mapping procedure is used to find the main or lead lymph node (tissue that fight infection) so it can be removed and checked for tumor cells. using lymphoscintigraphy to highlight and then surgically remove lymph nodes is standard way to treat skin cancer for many patients. the technetium 99 injections used for lymphoscintigraphy can be briefly painful due to the sensitivity of the nerve endings in the skin. the emla topical cream, which contains a numbing medicine to block pain from nerve endings, has been studied in breast cancer patients with a difference in pain reported, but this is the first time it has been studied in patients undergoing lymphoscintigraphy for skin cancer. this study may help researchers learn whether the use of emla cream may improve the associated pain at the time of the lymphoscintigraphy procedure.

primary objective: i. evaluate if the application of eutectic mixture of local anesthetics (emla) topical cream (2.5% lidocaine mixed with 2.5% prilocaine) prior to intra-dermal technetium 99 sulfur colloid (tc99 injection) for lymphoscintigraphy can improve associated pain. outline: patients are randomized to 1 of 2 cohorts. cohort 1: patients apply emla cream topically to skin 30 minutes prior to tc99 lymphoscintigraphy procedure. cohort 2: patients apply placebo cream topically to skin 30 minutes prior to tc99 lymphoscintigraphy procedure.

Eligibility criteria:
inclusion criteria: * biologic males or females * 18 - 99 years of age * histologically confirmed cutaneous melanoma, merkel cell carcinoma, squamous cell carcinoma, or other cutaneous malignancy for which lymphoscintigraphy and sentinel lymph node biopsy has been recommended. exclusion criteria: * known allergy or intolerance to emla cream, lidocaine, prilocaine, or any other local anesthetic * history of adhesive allergy * contraindication to tc99 injection for sentinel lymph node mapping * incarcerated patients * patients incapable of independently providing consent * mucosal or genital lymphoscintigraphy site * pregnancy * participant self-declared or ohio state university (osu) medical chart listing chronic pain as a pre-existing diagnosis * participants with chronic pain as defined by the centers for disease control and prevention (cdc):"pain lasting 3 months or more that can be caused by a disease or condition, injury, medical treatment, or unknown reason" excluding those with stable co-morbid conditions such as peripheral neuropathy, fibromyalgia, arthritis, and cancer-related pain who do not require narcotics. patients who require narcotics at any time within the 7-day period leading up to the procedure
motivational interviewing with dyslipidemic adolescents together with a parent versus with adolescents alone: a mixed methods clinical trial

Conditions: Dyslipidemias

Summary: the primary focus of this proposal is to address growing concern of overweight/ obese adolescents with hyperlipidemia. the proposed study is a 2-arm randomized controlled clinical trial to compare the effectiveness of motivational interviewing (mi) interventions with the parent and adolescent dyad versus adolescent (10-17yr) alone. the patients will be recruited from the lipid clinic at sick kids. the study hypothesis is that parent child dyad will have more success due to the possible synergetic effect compared to adolescents alone. the study's primary outcome is cholesterol levels (triglycerides/hdl ratio) and secondary outcomes include overall improvement in their lifestyle and their responses to the mi intervention.


Eligibility criteria:
inclusion criteria: * age at randomization: 10-17 years old * 12 hour fasting lipid profile with triglycerides ≥39 mg/dl (1.0 mmol/l) or hdl-c ≤46 mg/dl (1.2 mmol/l), and with non-hdl-c ≥123 mg/dl (3.2 mmol/l) * waist to height ratio ≥0.5. exclusion criteria: * on lipid lowering medication * non-english speaking * developmentally delayed

Keywords: motivational interviewing
investigation of sensory processing patterns of elderly individuals who have had hip fracture surgery

Conditions: Sensory Disorder; Sensory Processing Disorder; Hip Fractures; Fall Injury; Falling; Sensitivity; Elderly

Summary: this study aims to evaluate the sensory processing processes of elderly adults who have undergone fall-related hip fracture surgery in the last 6 months, according to different patterns, and to examine the relationship between physical performance, fall risk, fear of falling, and depression parameters that may be related to sensory processing.


Eligibility criteria:
inclusion criteria: * being 65 years or older * being able to stand independently for 30 seconds * being able to walk 3 m independently (with an assistive device if necessary) * getting a score of 24 or more on the mini mental test exclusion criteria: * hip fracture patients receiving medical treatment for pathological hip fractures, polytrauma, traffic accidents, bone tumors * having a history of diseases that may directly affect the evaluation process (neurological diseases such as parkinson's, alzheimer's and cancer) * having vision and hearing loss * having a psychiatric illness